Study to promote innovation in rural integrated telepsychiatry (SPIRIT): Rationale and design of a randomized comparative effectiveness trial of managing complex psychiatric disorders in rural primary care clinics.

OBJECTIVE: Managing complex psychiatric disorders like PTSD and bipolar disorder is challenging in Federally Qualified Health Centers (FQHCs) delivering care to U.S residents living in underserved rural areas. This protocol paper describes SPIRIT, a pragmatic comparative effectiveness trial designed to compare two approaches to managing PTSD and bipolar disorder in FQHCs. INTERVENTIONS: Treatment comparators are: 1) Telepsychiatry Collaborative Care, which integrates consulting telepsychiatrists into primary care teams, and 2) Telepsychiatry Enhanced Referral, where telepsychiatrists and telepsychologists treat patients directly. METHODS: Because Telepsychiatry Enhanced Referral is an adaptive intervention, a Sequential, Multiple Assignment, Randomized Trial design is used. Twenty-four FQHC clinics without on-site psychiatrists or psychologists are participating in the trial. The sample is patients screening positive for PTSD and/or bipolar disorder who are not already engaged in pharmacotherapy with a mental health specialist. Intervention fidelity is measured but not controlled. Patient treatment engagement is measured but not required, and intent-to-treat analysis will be used. Survey questions measure treatment engagement and effectiveness. The Short-Form 12 Mental Health Component Summary (SF-12 MCS) is the primary outcome. RESULTS: A third (34%) of those enrolled (n = 1004) are racial/ethnic minorities, 81% are not fully employed, 68% are Medicaid enrollees, 7% are uninsured, and 62% live in poverty. Mental health related quality of life (SF-12 MCS) is 2.5 standard deviations below the national mean. DISCUSSION: We hypothesize that patients randomized to Telepsychiatry Collaborative Care will have better outcomes than those randomized to Telepsychiatry Enhanced Referral because a higher proportion will engage in evidence-based treatment.

Use of a Mental Health Center Collaborative Care Team to Improve Diabetes Care and Outcomes for Patients With Psychosis.

OBJECTIVE: This study aimed to evaluate the feasibility, acceptability, and preliminary effectiveness (compared with usual care) of a collaborative care model to treat community mental health center (CMHC) patients with psychosis and poorly controlled diabetes. METHODS: Stakeholder input was used to adapt a primary care-based collaborative care intervention for CMHC settings. Thirty-five adult CMHC clients with type II diabetes and hemoglobin A1c (HbA1c) >8% or blood pressure >140/90 were randomized to receive either collaborative care or usual care. Change in HbA1c was evaluated between baseline and three months. Paired t tests were used for within-group comparisons. RESULTS: After three months, intervention participants had a statistically significant mean decrease in HbA1c of 1.1% (p=.049). There was no significant change in HbA1c in the usual-care group. CONCLUSIONS: This pilot demonstrates the feasibility and acceptability of implementing collaborative care in CMHC settings and its preliminary effectiveness in improving glycemic control in a high-risk population.

A collaborative care team to integrate behavioral health care and treatment of poorly-controlled type 2 diabetes in an urban safety net primary care clinic.

OBJECTIVE: Demonstrate the feasibility of implementing a collaborative care program for poorly-controlled type 2 diabetes and complex behavioral health disorders in an urban academically-affiliated safety net primary care clinic. METHODS: This retrospective cohort study evaluates multidisciplinary team care approach to diabetes in a safety net clinic, and included 634 primary care clinic patients with hemoglobin A1c (HbA1c)>9%. HbA1c, blood pressure, and depression severity were assessed at the initial visit and at the end of treatment, and compared to those of patients who were not referred to the team. RESULTS: The 151 patients referred to the program between March 2013 and November 2014 had a higher initial mean HbA1c: 10.6% vs. 9.4%, and were more likely to have depression (p=0.006), anxiety (p=0.04), and bipolar disorder (p=0.03), compared to the 483 patients who were not referred. During the 18-month study period, there was a mean decrease in HbA1c of 0.9 (10.6 to 9.4) among those referred to the team, compared to a mean decrease of 0.2 (9.4 to 9.2) among those not referred. This was a significantly greater percent change in HbA1c (p=0.008). CONCLUSION: The integration of behavioral healthcare into chronic care management of patients with diabetes is a promising strategy to improve outcomes among the high risk population in safety net settings.

Predictors of Sustained Prescription Opioid Use After Admission for Trauma in Adolescents.

PURPOSE: The study objectives are to describe the longitudinal trajectory of prescription opioid use among adolescents requiring a trauma admission and then identify predictors of sustained opioid use. METHODS: Randomly sampled adolescents (12-18 years) admitted to a Level I trauma center were surveyed. Follow-up assessments were obtained at 2, 5, and 12 months. Self-reported prescription opioid use, defined as "taking an opioid prescribed by a physician," was obtained at baseline and every follow-up time point. At the baseline interview, validated mental health measures and pain scales were obtained as well as preinjury substance use. A fixed-effects mixed Poisson regression analysis was performed to predict prescription opioid use over time. RESULTS: A total of 120 adolescents (mean age 15.5 years [1.9 standard deviation], 75% male) completed the baseline interview with 98% follow-up at 12 months. At baseline, 7% of adolescents reported prescription opioid use before their trauma, with rates of prescription opioid use of 52% at 2 months, 13.3% at 5 months, and 12.5% at 12 months after discharge. After adjusting for demographic characteristics and injury severity score, those with sustained prescription opioid use were more likely to report preinjury marijuana use and higher baseline pain scores. CONCLUSIONS: Approximately one in eight adolescents (12.5%) was using prescription opioids 12 months after injury hospitalization. Readily identifiable risk factors predicted sustained prescription opioid use, including preinjury marijuana use and baseline pain score. Screening for substance use including marijuana at the time of injury could help identify patients at risk for both substance use problems and sustained prescription opioid use.

Technology-Enhanced Stepped Collaborative Care Targeting Posttraumatic Stress Disorder and Comorbidity After Injury: A Randomized Controlled Trial.

Posttraumatic stress disorder (PTSD) and its comorbidities are endemic among injured trauma survivors. Previous collaborative care trials targeting PTSD after injury have been effective, but they have required intensive clinical resources. The present pragmatic clinical trial randomized acutely injured trauma survivors who screened positive on an automated electronic medical record PTSD assessment to collaborative care intervention (n = 60) and usual care control (n = 61) conditions. The stepped measurement-based intervention included care management, psychopharmacology, and psychotherapy elements. Embedded within the intervention were a series of information technology (IT) components. PTSD symptoms were assessed with the PTSD Checklist at baseline prerandomization and again, 1-, 3-, and 6-months postinjury. IT utilization was also assessed. The technology-assisted intervention required a median of 2.25 hours (interquartile range = 1.57 hours) per patient. The intervention was associated with modest symptom reductions, but beyond the margin of statistical significance in the unadjusted model: F(2, 204) = 2.95, p = .055. The covariate adjusted regression was significant: F(2, 204) = 3.06, p = .049. The PTSD intervention effect was greatest at the 3-month (Cohen's effect size d = 0.35, F(1, 204) = 4.11, p = .044) and 6-month (d = 0.38, F(1, 204) = 4.10, p = .044) time points. IT-enhanced collaborative care was associated with modest PTSD symptom reductions and reduced delivery times; the intervention model could potentially facilitate efficient PTSD treatment after injury.

Improving depression treatment for women: integrating a collaborative care depression intervention into OB-GYN care.

BACKGROUND: Women have higher rates of depression and often experience depression symptoms during critical reproductive periods, including adolescence, pregnancy, postpartum, and menopause. Collaborative care intervention models for mood disorders in patients receiving care in an OB-GYN clinic setting have not been evaluated. Study design and methodology for a randomized controlled trial of collaborative care depression management versus usual care in OB-GYN clinics and the details of the adapted collaborative care intervention and model implementation are described in this paper. METHODS: Women over age 18 years with clinically significant symptoms of depression, as measured by a Patient Health Questionnaire-9 (PHQ-9) score ≥10 and a clinical diagnosis of major depression or dysthymia, were randomized to the study intervention or to usual care and were followed for 18 months. The primary outcome assessed was change over time in the SCL-20 depression scale between baseline and 12 months. BASELINE RESULTS: Two hundred five women were randomized: 57% white, 20% African American, 9% Asian or Pacific Islander, 7% Hispanic, and 6% Native American. Mean age was 39 years. 4.6% were pregnant and 7.5% were within 12 months postpartum. The majority were single (52%), and 95% had at least the equivalent of a high school diploma. Almost all patients met DSM IV criteria for major depression (99%) and approximately 33% met criteria for dysthymia. CONCLUSIONS: An OB-GYN collaborative care team, including a social worker, a psychiatrist, and an OB-GYN physician, who met weekly and used an electronic tracking system for patients was the essential element of the proposed depression care treatment model described here. Further study of models that improve quality of depression care that are adapted to the unique OB-GYN setting is needed.

Substance use and posttraumatic stress disorder symptoms in trauma center patients receiving mandated alcohol screening and brief intervention.

In an effort to integrate substance abuse treatment at trauma centers, the American College of Surgeons has mandated alcohol screening and brief intervention (SBI). Few investigations have assessed trauma center inpatients for comorbidities that may impact the effectiveness of SBI that exclusively focuses on alcohol. Randomly selected SBI eligible acute care medical inpatients (N=878) were evaluated for alcohol, illegal drugs, and symptoms consistent with a diagnosis of posttraumatic stress disorder (PTSD) using electronic medical record, toxicology, and self-report assessments; 79% of all patients had one or more alcohol, illegal drug, or PTSD symptom comorbidity. Over 70% of patients receiving alcohol SBI (n=166) demonstrated one or more illegal drug or PTSD symptom comorbidity. A majority of trauma center inpatients have comorbidities that may impact the effectiveness of mandated alcohol SBI. Investigations that realistically capture, account for, and intervene upon these common comorbid presentations are required to inform the iterative development of college policy targeting integrated substance abuse treatment at trauma centers.

Cost-effectiveness of a multicondition collaborative care intervention: a randomized controlled trial.

CONTEXT: Patients with depression and poorly controlled diabetes mellitus, coronary heart disease (CHD), or both have higher medical complication rates and higher health care costs, suggesting that more effective care management of psychiatric and medical disease control might also reduce medical service use and enhance quality of life. OBJECTIVE: To evaluate the cost-effectiveness of a multicondition collaborative treatment program (TEAMcare) compared with usual primary care (UC) in outpatients with depression and poorly controlled diabetes or CHD. DESIGN: Randomized controlled trial of a systematic care management program aimed at improving depression scores and hemoglobin A(1c) (HbA(1c)), systolic blood pressure (SBP), and low-density lipoprotein cholesterol (LDL-C) levels. SETTING: Fourteen primary care clinics of an integrated health care system. PATIENTS: Population-based screening identified 214 adults with depressive disorder and poorly controlled diabetes or CHD. INTERVENTION: Physician-supervised nurses collaborated with primary care physicians to provide treatment of multiple disease risk factors. MAIN OUTCOME MEASURES: Blinded assessments evaluated depressive symptoms, SBP, and HbA(1c) at baseline and at 6, 12, 18, and 24 months. Fasting LDL-C concentration was assessed at baseline and at 12 and 24 months. Health plan accounting records were used to assess medical service costs. Quality-adjusted life-years (QALYs) were assessed using a previously developed regression model based on intervention vs UC differences in HbA(1c), LDL-C, and SBP levels over 24 months. RESULTS: Over 24 months, compared with UC controls, intervention patients had a mean of 114 (95% CI, 79 to 149) additional depression-free days and an estimated 0.335 (95% CI, -0.18 to 0.85) additional QALYs. Intervention patients also had lower mean outpatient health costs of $594 per patient (95% CI, -$3241 to $2053) relative to UC patients. CONCLUSIONS: For adults with depression and poorly controlled diabetes, CHD, or both, a systematic intervention program aimed at improving depression scores and HbA(1c), SBP, and LDL-C levels seemed to be a high-value program that for no or modest additional cost markedly improved QALYs. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00468676

Staying connected: a feasibility study linking American Indian and Alaska Native trauma survivors to their tribal communities.

The objective of this investigation was to assess the feasibility of a culturally tailored care management intervention for physically injured American Indian/Alaska Native (AI/AN) patients. The intervention was initiated at a Level I trauma center and aimed to link AI/AN patients to their distant tribal communities. Thirty AI/AN patients were randomized to the intervention or to usual care. Assessments at baseline, 3 months, and 6 months included self-reported lifetime cumulative trauma burden, Native healing requests, and symptoms of posttraumatic stress, depression, and alcohol use. Generalized estimating equations ascertained differences between groups over time. Ninety-four percent of eligible patients participated; follow-up at 3 and 6 months was 83%. Participants had high numbers of lifetime traumas (mean = 5.1, standard deviation = 2.6). No differences between the intervention and control groups were observed in posttraumatic stress symptoms, depression symptoms, or alcohol use at baseline or follow-up time points. Among intervention patients, 60% either requested or participated in traditional Native healing practices and 75% reported that the intervention was helpful. This effectiveness trial demonstrated the feasibility of recruiting and randomizing injured AI/AN patients. Future efforts could integrate evidence-based interventions and traditional Native healing into stepped collaborative care treatment programs.

Evaluation of the PHQ-2 as a brief screen for detecting major depression among adolescents.

OBJECTIVE: To examine the validity of the Patient Health Questionnaire 2 (PHQ-2), a 2-item depression-screening scale, among adolescents. METHODS: After completing a brief depression screen, 499 youth (aged 13-17 years) who were enrolled in an integrated health care system were invited to participate in a full assessment, including a longer depression-screening scale (Patient Health Questionnaire 9-item depression screen) and a structured mental health interview (Diagnostic Interview Schedule for Children). Eighty-nine percent (n = 444) completed the assessment. Criterion validity and construct validity were tested by examining associations between the PHQ-2 and other measures of depression and functional impairment. RESULTS: A PHQ-2 score of > or =3 had a sensitivity of 74% and specificity of 75% for detecting youth who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria for major depression on the Diagnostic Interview Schedule for Children and a sensitivity of 96% and specificity of 82% for detecting youth who met criteria for probable major depression on the Patient Health Questionnaire 9-item depression screen. On receiver operating characteristic analysis, the PHQ-2 had an area under the curve of 0.84 (95% confidence interval: 0.75-0.92), and a cut point of 3 was optimal for maximizing sensitivity without loss of specificity for detecting major depression. Youth with a PHQ-2 score of > or =3 had significantly higher functional-impairment scores and significantly higher scores for parent-reported internalizing problems than youth with scores of <3. CONCLUSIONS: The PHQ-2 has good sensitivity and specificity for detecting major depression. These properties, coupled with the brief nature of the instrument, make this tool promising as a first step for screening for adolescent depression in primary care.

Factors associated with detection and receipt of treatment for youth with depression and anxiety disorders.

OBJECTIVE: Anxiety and depression are common among youth and are associated with significant morbidity. Few youth with depression are diagnosed and receive treatment for these disorders. The purpose of this study was to examine the rate of recognition and management among an insured population and the factors associated with evidence of detection among youth. METHODS: Structured mental health interviews assessing depression and anxiety diagnoses were completed with a random sample of 581 youth (age range 11-17 years) from an integrated health care system. Administrative data on medical and pharmacy services were used to examine any evidence of detection by the medical system in the prior 12 months. RESULTS: Fifty-one youth met criteria for an anxiety or depressive disorder. Twenty-two percent of these youth with an anxiety or depressive disorder as defined in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition had evidence of detection or treatment. Factors associated with detection and treatment included having diagnosis of a depressive disorder (with or without an anxiety disorder), more depressive symptoms, greater functional impairment, a higher number of primary care visits in the prior year, and higher parent-reported externalizing symptoms. On multivariate analysis, having more depressive symptoms and a higher number of primary care visits were significant predictors of detection and receipt of treatment. CONCLUSIONS: The rate of detection and treatment of anxiety and depressive disorders is very low in this age group and suggests a need for increased focus on detection, particularly in light of recent evidence suggesting decreases in diagnosis and treatment among youth following the black box warning regarding antidepressant medications.

Does occasional cannabis use impact anxiety and depression treatment outcomes?: Results from a randomized effectiveness trial.

This study investigated the extent to which occasional cannabis use moderated anxiety and depression outcomes in the Collaborative Care for Anxiety and Panic (CCAP) study, a combined cognitive-behavioral therapy (CBT) and pharmacotherapy randomized effectiveness trial. Participants were 232 adults from six university-based primary care outpatient clinics in three West Coast cities randomized to receive either the CCAP intervention or the usual care condition. Results showed significant (P<.01) evidence of an interaction between treatment group (CCAP vs. usual care) and cannabis use status (monthly vs. less than monthly) for depressive symptoms, but not for panic disorder or social phobia symptoms (all P>.05). Monthly cannabis users' depressive symptoms improved in the CCAP intervention just as much as those who used cannabis less than monthly, whereas monthly users receiving usual care had significantly more depressive symptoms than those using less than monthly. A combined CBT and medication treatment intervention may be a promising approach for the treatment of depression among occasional cannabis users.

A controlled study of repetitive transcranial magnetic stimulation in medication-resistant major depression.

BACKGROUND: Repetitive transcranial magnetic stimulation (TMS) as a treatment for depression has shown statistically significant effects, but the clinical significance of these effects has been questioned. METHODS: Patients with medication-resistant depression were randomized to receive 15 sessions of active or sham repetitive TMS delivered to the left dorsolateral prefrontal cortex at 110% the estimated prefrontal cortex threshold. Each session consisted of 32 trains of 10 Hz repetitive TMS delivered in 5-second trains. The primary end point was treatment response defined as a >or=50% decrease in Hamilton Depression Rating Scale (HDRS) score at both 1 and 2 weeks following the final repetitive TMS treatment. Remission was defined as a HDRS score < 8. RESULTS: The response rate for the TMS group was 30.6% (11/35), significantly (p = .008) greater than the 6.1% (2/33) rate in the sham group. The remission rate for the TMS group was 20% (7/35), significantly (p = .033) greater than the 3% (1/33) rate in the sham group. The HDRS scores showed a significantly (p < .002) greater decrease over time in the TMS group compared with the sham group. CONCLUSIONS: Transcranial magnetic stimulation can produce statistically and clinically significant antidepressant effects in patients with medication-resistant major depression.

Use of herbal medicine in primary care patients with mood and anxiety disorders.

Studies have documented the increasing use of complementary and alternative medicine over the last decade, especially in distressed individuals with symptoms of anxiety, depression, and pain. Herbal medicine is a specific form of complementary and alternative medicine often used by individuals seeing traditional medical practitioners and, hence, has the potential to interact with other medically prescribed treatments. The study examined the use of herbal medicine in a group of primary care patients with symptoms of anxiety and depression. The rate of use of herbal medicines was 11%, and use was selectively associated with a diagnosis of major depression, higher education, and a lower burden of medical illness. Use was not associated with receipt of pharmacotherapy or psychotherapy for anxiety or depression.